Author + information
- Received June 29, 2009
- Accepted July 9, 2009
- Published online October 1, 2009.
- Joost D.E. Haeck, MD⁎,
- Karel T. Koch, MD, PhD⁎,⁎ (, )
- Luc Bilodeau, MD†,
- René J. Van der Schaaf, MD⁎,
- José P.S. Henriques, MD, PhD⁎,
- Marije M. Vis, MD⁎,
- Jan Baan Jr, MD, PhD⁎,
- Allard C. Van der Wal, MD, PhD‡,
- Jan J. Piek, MD, PhD⁎,
- Jan G.P. Tijssen, PhD⁎,
- Mitchell W. Krucoff, MD§ and
- Robbert J. De Winter, MD, PhD⁎
- ↵⁎Reprint requests and correspondence:
Dr. Karel T. Koch, Department of Cardiology, Cardiac Catheterization Laboratory B2-125, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands
Objectives The purpose of this study was to evaluate the effectiveness of combined proximal embolic protection with thrombus aspiration (Proxis Embolic Protection System [St. Jude Medical, St. Paul, Minnesota]) in ST-segment elevation myocardial infarction patients.
Background Embolization during primary percutaneous coronary intervention (PCI) may result in microvascular obstruction, reduced myocardial perfusion, and impaired prognosis.
Methods Two hundred eight-four patients were randomized to primary PCI with the Proxis system versus primary PCI alone after angiography. The primary end point was the occurrence of complete (≥70%) ST-segment resolution (STR) at 60 min measured by continuous ST-segment Holter.
Results There was no significant difference in the occurrence of the primary end point (80% vs. 72%, p = 0.14). However, immediate complete STR (at time of last contrast) occurred in 66% of Proxis-treated patients and 50% in control patients (absolute difference, 16.3%; 95% confidence interval: 4.3% to 28.2%; p = 0.009). A significant lower ST-segment curve area (0 to 3 h after primary PCI) was observed in the Proxis arm (5,192 μV/min vs. 6,250 μV/min, p = 0.037). Major adverse cardiac and cerebral events at 30 days occurred with similar frequency in both groups (6 vs. 10).
Conclusions There was no significant difference in complete STR at 60 min in this proof-of-concept study. However, we observed a significant difference in immediate complete STR in Proxis-treated patients, better STR at later time points, and a reduction of electrocardiogram injury current over time, compared with control patients. The results suggest that primary PCI with the Proxis system may lead to better immediate microvascular flow in ST-segment elevation myocardial infarction patients. (The PREPARE Study; ISRCTN71104460)
- ST-segment elevation myocardial infarction
- primary percutaneous coronary intervention
- combined proximal embolic protection and thrombus aspiration
This study is supported by grants from St. Jude Medical and from the University of Amsterdam.
- Received June 29, 2009.
- Accepted July 9, 2009.
- American College of Cardiology Foundation